Pharmaceutical Research

, Volume 22, Issue 4, pp 499–511

Method Validation and Measurement of Biomarkers in Nonclinical and Clinical Samples in Drug Development: A Conference Report


    • MDS Pharma Services
  • Russ S. Weiner
    • Bristol-Myers Squibb
  • Jeff M. Sailstad
    • Trimeris Inc.
  • Ronald R. Bowsher
    • LINCO Diagnostic Services
  • Dean W. Knuth
    • Jasper Clinic
  • Peter J. O’Brien
    • Eli Lilly and Company
  • Jean L. Fourcroy
    • Walter Reed Army Hospital
  • Rakesh Dixit
    • Merck and Company, Inc.
  • Lini Pandite
    • GlaxoSmithKline
  • Robert G. Pietrusko
    • Millenium Pharmaceuticals
  • Holly D. Soares
    • Pfizer Global Research
  • Valerie Quarmby
    • Genetech, Inc.
  • Ole L. Vesterqvist
    • Bristol-Myers Squibb
  • David M. Potter
    • Pfizer Global Research
  • James L. Witliff
    • University of Louisville
  • Herbert A. Fritche
    • MD Anderson HospitalUniversity of Texas
  • Timothy O’Leary
    • Food and Drug Administration
  • Lorah Perlee
    • Molecular Staging Inc.
  • Sunil Kadam
    • Eli Lilly and Company
  • John A. Wagner
    • Merck and Company, Inc.
Conference Report

DOI: 10.1007/s11095-005-2495-9

Cite this article as:
Lee, J., Weiner, R., Sailstad, J. et al. Pharm Res (2005) 22: 499. doi:10.1007/s11095-005-2495-9

No Heading

Biomarkers are increasingly used in drug development to aid scientific and clinical decisions regarding the progress of candidate and marketed therapeutics. Biomarkers can improve the understanding of diseases as well as therapeutic and off-target effects of drugs. Early implementation of biomarker strategies thus promises to reduce costs and time-to-market as drugs proceed through increasingly costly and complex clinical development programs. The 2003 American Association of Pharmaceutical Sciences/Clinical Ligand Assay Society Biomarkers Workshop (Salt Lake City, UT, USA, October 24–25, 2003) addressed key issues in biomarker research, with an emphasis on the validation and implementation of biochemical biomarker assays, covering from preclinical discovery of efficacy and toxicity biomarkers through clinical and postmarketing implementation. This summary report of the workshop focuses on the major issues discussed during presentations and open forums and noted consensus achieved among the participants on topics from nomenclature to best practices. For example, it was agreed that because reliable and accurate data provide the basis for sound decision making, biomarker assays must be validated in a manner that enables the creation of such data. The nature of biomarker measurements often precludes direct application of regulatory guidelines established for clinical diagnostics or drug bioanalysis, and future guidance on biomarker assay validation should therefore be adaptable enough that validation criteria do not stifle creative biomarker solutions.

Key Words:

biomarkersnonclinical and clinical drug developmentquantitative method development and validation



American Association of Pharmaceutical Sciences


below quantifiable limit


Center for Drug Evaluation and Research


Centers for Medicare & Medicaid Services


Clinical Ligand Assay Society


Clinical Lab Improvement Amendments


good laboratory practices


Ligand Binding Assay Bioanalytical Focus Group


lower limit of detection


lower limit of quantification


National Committee for Clinical Laboratory Standards






Office of in Vitro Diagnostics Device Evaluation and Safety


quality controls


upper limit of quantification

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Copyright information

© Springer Science+Business Media, Inc. 2005